Stability Indicating Quality by Design-based Development and Validation of Bilastine and Montelukast by Ultra Performance Liquid Chromatography Method

Abstract

Background: The current work, which was conducted under the quality by design (QbD) paradigm, aims to establish the optimization of ultra-performance liquid chromatography (UPLC) using the design of experiments and response surface theory, such as central composite design (CCD), in order to achieve a good separation and resolution. Methods: The mobile phase was composed of methanol (20:80% v/v) and 0.1% tri fluro amine (TFA) buffer, and chromatographic separation was performed on column phenomenex C18 (50 mm x 4.6 mm x 2.5 m) at a flow rate of 0.4 mL/ min. Montelukast (MON) and bilastine (BIL) were both detected at 260 nm. The suggested method was approved in accordance with International Council for Harmonization (ICH) recommendations. Results: The created technique successfully separates both BIL and MON with a chromatographic resolution of 6.4. The technique was linear for BIL and MON concentrations of 0.5–3.0 μg/mL and 0.25–1.5, respectively, and recovery rates ranged from 99–100%. The drug compounds had distinct degradation products that were identified in stress patterns. Conclusion: For the quantification of BIL and MON in the combination tablet, a precise, simple, reliable, and accurate UPLC method was designed. According to the method validation, it was possible to successfully separate two medicines from their degradants utilizing aQbD techniques.

A Stability Indicating RP-HPLC Method for the Estimation of Nebivolol Hydrochloride in Human Plasma

“…The validation of the bioanalytical technique for estimating NBH was performed in accordance with USFDA guidelines. 11…”

Robust method operable design region for economical and eco‐friendly chromatographic analysis of azilsartan medoxomil and cilnidipine by incorporating a hybrid approach of green analytical chemistry and analytical quality by design

“…Numerous RP-HPLC methods have been published in the literature for the estimation of AZL alone and with other drugs [12][13][14][15][16][17][18][19][20], CIL alone, and with other drugs [21][22][23][24][25] in their FDCs. Recently, some chromatographic methods such as RP-HPLC and ultra-performance liquid chromatography methods have been reported in the literature for simultaneous estimation of AZL and CIL using class 2 solvents (methanol and acetonitrile) as mobile phase and diluent [26][27][28]. However, no RP-HPLC method has been reported yet for concomitant analysis of AZL and CIL using relatively safer class 3 category solvents according to the concept of GAC.…”

Stability Indicating Method Development and Validation for the Simultaneous Estimation of Azilsartan and Chlorthalidone in their Bulk and Pharmaceutical Dosage Forms by RP-UPLC

“…[1][2][3] Chlorthalidone (Figure 2) is a diuretic drug from the thiazide diuretics category which is chemically named as 2-chloro-5(2,3-dihydroxy-3-oxo-1H-isoindol-1-yl)benzenesulfonamide inhibits sodium and chloride ions reabsorption in the distal convoluted tubule by blocking the Na + / Clsymporter. [4][5][6] The present study is aimed towards the development and followed by validation of Azilsartan and Chlorthalidone in their pharmaceutical and bulk formulations using RP-UPLC method which is relatively a new technique. [7][8][9] The literature survey on selected drugs reveals that only HPLC (High Performance Liquid Chromatography) analysis is carried out so far hence the present work is focused towards developing a new method for the determination of Chlorthalidone and Azilsartan using UPLC.…”